Specialist, Manufacturing Sciences and Analytical Technologies - Cell Therapies
Takeda Pharmaceutical Company - Boston, MA
posted 16 days ago
About the position
Are you looking for a patient-focused company that will inspire you and support your career? If so, you can be empowered to take charge of your future at Takeda. Join us as a Specialist, MSAT, in our Cambridge office. At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people worldwide. Here, you will be a vital contributor to our inspiring, bold mission.
Responsibilities
- Support process and technology transfers, change management, technical deviation, and technical process support for cell therapy projects.
- Independently design and execute experiments to support process evaluation and technology transfer.
- Identify aspects required for GMP compliance and perform experiments to validate the changes.
- Author and execute qualification and validation protocols, working with the Technical Operation and Quality Team.
- Develop and manage tools and templates that can be used to assess the impact and criticality of parameters and attributes.
- Revise and edit master batch records using an Electronic Batch Record (EBR) platform.
- Support operator training and act as the manufacturing process SME.
- Author and execute Life Cycle Management process activities and define/coordinate the related Change Control Activities.
- Assist in integrating and implementing digital data enterprises, including electronic Batch Records and data systems.
Requirements
- Bachelor's degree in biotechnology, biology, engineering or related pharmaceutical science and 1+ years relevant cell processing or aseptic processing experience in Manufacturing or Process Development (direct experience working with CAR-T is preferred) or master's degree in chemistry, biotechnology, biology, engineering or related pharmaceutical science.
- Previous hands-on experience in a cGMP or clinically regulated environment is preferred.
- Knowledge of aseptic processing in ISO 5 biosafety cabinets strongly preferred.
- Manufacturing experience in biopharmaceutical operations, preferably involving cell cultures or Regenerative Medicines.
Nice-to-haves
- Teamwork - Ability to work well in a highly cross-functional team environment.
- Communication - Able to express oneself clearly and concisely within team; documents issues and/or concerns concisely with colleagues; timely and effectively communicates issues to supervisor.
- Analytical and Problem-Solving Skills - Able to troubleshoot critical issues or problems and determine causes and possible solutions using appropriate information.
- Organization - Exercises good time management and prioritization skills and can successfully manage multiple tasks simultaneously.
- Motivated - Self-motivated and willing to accept temporary responsibilities outside of initial job description.
Benefits
- Medical, dental, vision insurance
- 401(k) plan and company match
- Short-term and long-term disability coverage
- Basic life insurance
- Tuition reimbursement program
- Paid volunteer time off
- Company holidays
- Well-being benefits
- Up to 80 hours of sick time per calendar year
- Up to 120 hours of paid vacation for new hires
